IRB Policies

Table of contents

I am a member of the Mount Mary College Institutional Review Board. Deadlines are clearly given in the directions for the protocol.

Mount Mary College

Institutional Review Board (IRB)

for the Protection of Human Subjects

Application for IRB Review

DATA COLLECTION CANNOT BEGIN

UNTIL THE IRB HAS APPROVED THIS PROJECT

Directions:

·Faculty and student researchers, as well as student research advisors, should read all relevant information on the College IRB page in My Mount Mary before initiating an application. This includes full knowledge of the US Department of Health and Human Services Code of Federal Regulations Title 45 (Public Welfare), Part 46 (Protection of Human Subjects). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

The IRB application must be filed and approved by the IRB prior to any Mount Mary College faculty, staff, or student (undergraduate or graduate), initiating a research project/study.

If there is a cooperating institution, attach copy of their IRB approval.

In the case of a student research project, the student may complete the IRB application but the student’s research advisor must sign and submit the application to the IRB for approval.It is the responsibility of the faculty research advisor to ensure that student applications and all attachments (e.g. informed consent forms and survey instruments) are in their final edited form. Even though a student research project may qualify as Exempt from full IRB review, the research advisor may request the student to complete and submit a full IRB application.

Complete this application on-line; click on boxes to enter your responses, print it out and obtain signatures.(Handwritten applications will not be accepted.)For your benefit, save the completed application in case it needs to be revised and resubmitted.

Submit the completed application, with required signatures and attachments, to Marmy Clason, IRB Chair, Communications Department.(Emailed applications will not be accepted.)

This is a professional document; please check spelling, grammar and punctuation.

·Allow a minimum of 10 working days to process your application. Make sure this time frame is accounted for when considering initiation of data collection and due dates for student projects.

·For class projects you must submit IRB applications to the IRB Chair by October 31st of the fall semester and March 31st for the spring semester. For summer classes, please consult with the IRB Chair.

·Upon receipt of the IRB letter of approval, data collection may begin.

I. Required Documentation(No action will be taken without these attachments.)

Are the following attached to the IRB application?

Consent application

Yes

Applications should include explanation of procedures, risk, safeguards, freedom to withdraw, confidentiality, offer to answer inquiries, third party referral for concerns, signature and date. See Appendix.A.

Questionnaire/Survey Instrument(s)

Yes

If survey is being conducted verbally, a copy of the introductory comments and survey questions being asked must be attached to this application.If survey includes focus group questions, a complete list of the question should be attached.For research using a published/purchased instrument, a photocopy of the instrument will suffice.

Verification of Human Subjects Training

Yes

Copy of transcript, certificate or other evidence

.

Copy of cooperating institution’s IRB approval.

Yes

Not required if there is no cooperating institution.

.

If student, list Research Advisor and complete Section II.Research Advisor must provide requested information and verify.

Research Advisor’s Name:

Department:

Email:

Phone:

Research Advisor: Have you completed Human Subject’s Training?

Research advisor’s signature indicates responsibility for student compliance with all IRB requirements.

Does the research involve only the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens?

Yes

No

Will the information be recorded by the investigator in such a manner that the subjects cannot be identified directly or through identifiers linked to the subjects? (See Appendix B)

Yes

No

If both questions are answered yes, stop here, proceed to Section I Required Documentation, and submit application.

5) Does the research meet the criteria for exempt category 5 (federal program research)? [45 CFR 46.101 (b) (5)]

Does the research involve studying, evaluating or examining federal public benefit or service programs?

Yes

No

Is the research conducted through a federal agency?

Yes

No

If both questions are answered yes, stop here, proceed to Section I Required Documentation, and submit application.

6) Does the research meet the criteria for exempt category 6 (taste and food quality)?

[45 CFR 46.101 (b) (6)]

Does the research involve a taste and food quality evaluation or consumer acceptance study?

Yes

No

Does the food consumed contain no additives, or a limited amount of food additives at or below a level approved by the FDA or EPA or the Food Safety and Inspection Service of the U.S. Department of Agriculture?

Yes

No

If both questions are answered yes, stop here, proceed to Section I Required Documentation, and submit application.

2) What process is used for obtaining informed consent (attach the informed consent application)? See Appendix for consent application.

3) Does the research include special populations?

Minors under 18 years of age?

Yes

No

Persons legally incompetent?

Yes

No

Prisoners?

Yes

No

Pregnant women, if affected by research?

Yes

No

Persons institutionalized?

Yes

No

Persons mentally incapacitated?

Yes

No

4) If YES, describe additional precautions included in the research procedures.

5) Does the research involve any of the following procedures?

False or misleading information to subjects?

Yes

No

Withholds information such that their informed consent might be questioned?

Yes

No

Uses procedures designed to modify the thinking, attitudes, feelings, or other aspects of the behavior of the subjects?

Yes

No

6) If YES, describe the rationale for using procedures, how the human subjects will be protected and what debriefing procedures are used.

7) Does the research involve measurement in any of the following areas?

Sexual behaviors?

Yes

No

Drug use?

Yes

No

Illegal conduct?

Yes

No

Use of alcohol?

Yes

No

8) If YES, describe additional precautions included in the research procedures.

9) Are any portions of the research being conducted online?

Survey posted on a website?

Yes

No

If yes, assure anonymity

URL for survey includes information that could identify participants?

Yes

No

If yes, assure anonymity

Invitation to participate sent by email?

Yes

No

If yes, assure anonymity

Items use drop-down box?

Yes

No

If yes, assure that items allow choice of “no response”

10) If YES, describe additional procedures.

11) Describe the methods used to ensure confidentiality of data obtained.

Risks and Benefits

1) Describe risks to the subjects and the precautions that will be taken to minimize them. (Risk includes any potential or actual physical risk of discomfort, harassment, invasion of privacy, risk of physical activity, risk to dignity and self-respect, and psychological, emotional or behavioral risk.)

2) Describe the benefits to subjects and/or society. (These will be balanced against risk.)

Appendix A: Required Elements of Informed Consent

Informed consent is the process of communicating to a prospective participant, in easy-to-understand language (usually sixth- to eighth-grade level), all that he or she needs to know about participating in a research project, and then obtaining the prospective participant's agreement to participate. The following ten elements of consent are widely recognized and, except under certain specific conditions, must be included in all consent processes and forms:

1.An explanation of the study, including goals, procedure, and a statement that the study is research.

2.A description of what participants are expected to do and expected length of participation.

3.A description of any likely risks or discomforts for the participants. Potential harm should be explained in language that participants can understand and that relate to everyday life.

4.A description of any likely benefits to the participant or to others.

5.A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant.

6.A statement describing the level of privacy assured for collected information (anonymous, confidential) and how private information and information security will be managed.

7.An explanation of whom to contact for answers to questions about the research. When a Mount Mary student is the principal investigator, the name and phone number of a supervising faculty member is required.

8.An explanation of whom to contact for concerns about the participant’s privacy and rights, which for Mount Mary College is its IRB Chair.

9.For research involving more than minimal risk, a statement describing any compensation for injuries and contact information. (Minimal risk is a risk of harm to the participant that is no greater than the risk encountered in normal, day-to-day activities or during routine physical or psychological examinations.)

10.A statement that research participation is voluntary and the participant may withdraw from participation at any time, without penalty or loss of benefits to which the participant is otherwise entitled. If the participant is a patient or client receiving medical, psychological, counseling, or other treatment services, there should be a statement that withdrawal from the study will not jeopardize or otherwise affect any treatment or services the participant is currently receiving or may receive in the future. Participants also should be told whether their data will be destroyed should they withdraw from the study. If a survey instrument or interview questions are used and some questions deal with sensitive issues, the participants should be told they may refuse to answer individual questions.

Appendix B: IRB De-Identification Standard for Information

Protecting the privacy of research participants is a general concern in the vast majority of research projects. The degree to which privacy needs to be ensured or maintained depends on the nature of the particular research, its setting, and the research participants. Researchers share a general obligation to design their research to reduce the risks of disclosure of collected information about individual research participants. Thus, the present standard for de-identification of information is useful as a guide to protecting privacy even when it is not required or fully required. In this regard, the researcher should consider the following question when collecting and handling data.

Does the information I am accessing, recording, and/or disclosing contain identifiers? Simple access to information may be without concern, for example when the researcher is an employee who routinely handles the records in carrying out his or her position. But, the presence of identifiers in any recorded or disclosed information in the research means the information is not anonymous and so does not meet the IRB de-identification standard, which in some cases may also disqualify the research from exemption from IRB review. The IRB de-identification standard includes all 18 direct identifiers specified in the HIPAA Privacy Rule de-identification standard—45 CFR 164.514(b). Below are listed specific direct and indirect identifiers that lead to information not being anonymous.

Identifiers: Direct; Indirect

One way to distinguish between information that is truly anonymous and information that is simply being kept confidential is to determine whether the data set contains direct or indirect identifiers. Information in a data set with either direct or indirect identifiers is not anonymous.

Direct Identifiers include:

·Names

·Addresses

·Telephone and fax numbers

·Email addresses, IP addresses, and URLs

·Social Security numbers

·Medical record numbers

·Account numbers, such as those associated with bank accounts or health plans

Indirect Identifiers can be combined with publicly available information to identify individuals. The determination of indirect identifiers depends on the nature of the research participants. For example, in a study of residents of the state of Wisconsin, the information that someone graduated from one of the UW system schools probably would not be a unique identifier. However, in a study of small business leaders in Racine, WI, the same information might well apply to only one individual. In general, if any single variable in a data set applies to fewer than five participants, it is considered a potential indirect identifier.

Examples of indirect identifiers include:

·Detailed geographical information, such as state, county, or census tract of residence